Raising The Curtain On Real-World Evidence
RWE continues to animate expectations far and wide, but its success calls for level-headed pragmatism
Unless you have been living under an exceptionally large rock, you will have heard the furore building around real-world evidence (RWE). It is increasingly touted as pharma’s golden ticket and it is easy to see why. The explosion of electronic health records (EHRs), amongst other technological leaps, is providing pharma with unprecedented insight into the patient experience. The hype around health data is even spilling out into the national conversation, as The Economist’s recent cover story suggests.
RWE may prove to be transformative, but harnessing its potential requires a measured understanding of both its inherent value and the mammoth task at hand.
“RWE is about information that is generated from multiple millions of one-to-one interactions,” says David Williams, Global Engagement Lead Real World Data — General Medicine and Emerging Markets and Consumer Health at Sanofi. “It is immediate, it is closer to the patient and it is relevant. While it is just a ‘one person’ piece of data, the value comes if you extrapolate that up to multiple millions.”
How best to extrapolate this data and to what end prompts serious head-scratching, he says. “The challenge for implementation is a fundamental one; it is about how people understand what the evidence is there to do, and how to choose the best methodology to exploit it.
“It’s almost like you have to go back to basics in the evidence hierarchy to understand what you want to achieve. [We are] making assumptions in various fields,” says Williams. “It’s always about going back to understanding the patient’s perspective of what the evidence needs are required in best treatment.”
When it comes to recruiting the right person for the job, the challenge is two-fold, he says. Recruiting people with specialist skills or even accessing people with those specific skills can be problematic. “A whole group of people in industry will need to be upskilled and trained in this area. That’s what we are doing at Sanofi and those are the biggest short-term challenges Unless you understand this stuff, you can’t use it in the right space.”
It will require buy-in at all levels, he stresses. “I see it as necessitating both a top-down and bottom-up approach. Strong leadership is needed to change rigid mindsets, whereas training and recruitment will help transform the attitude of the company.”
Industry is finally opening its arms to RWE, but as it continues to play a greater role in healthcare decisions, its reception by other stakeholders will be mixed, admits Williams. “It depends which customer group we are talking about on whether this will be adopted – regulators will require some encouragement, while doctors will be pleased to see the use of RWE evidence, as they will recognise the value it can have for advancing the development of better medicines for their patients.”
David Williams will be sharing his insights at the Real-World Evidence and Access Europe 2018 event between the 24th and 25th of April
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